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Why this ineffective decongestant is still on pharmacy shelves

Medical Pharmaceutical Translations • Jan 9, 2023 12:00:00 AM

This winter, many people - maybe even you, dear reader - will probably purchase cold medicine at some point. But while a number of over-the-counter cold medications claim to work as decongestants, an alarming number of them are totally ineffective.

It’s an open secret that phenylephrine, a common over-the-counter oral decongestant, doesn’t work. Studies have shown it’s no more effective than a placebo. Doctors and pharmacists often tell their patients to avoid it. And yet, phenylephrine remains widely and easily available, sometimes even unavoidable. Let’s look at why - and what patients and healthcare providers can do.

What is phenylephrine?

Phenylephrine is a vasoconstrictor most notably used as a treatment for hemorrhoids, certain ocular issues, low blood pressure, and priapism.

It’s effective for all of these issues, but not, it turns out, as a decongestant when taken orally.

Why did phenylephrine get FDA approval as a decongestant?

For many years, pseduoephedrine was a common over the counter nasal decongestant. It’s consistently been proven to be effective, and has relatively few side effects for most of the population. Perfect!

….Except, it's also a useful substance for making methamphetamine.

In an effort to crack down on meth labs and meth abuse, the US government passed the Combat Methamphetamine Epidemic Act in 2005. Since then, it’s become a lot harder (though, thankfully, not impossible! More on that in a bit.) for consumers to purchase pseudoephedrine over the counter.

Meanwhile, in order to sell medications more easily and to ensure compliance with the new legislation, many major pharma companies substituted phenylephrine for pseudoephedrine in a number of their over-the-counter cold and flu medications.

Phenylephrine is found in popular medications like Mucinex, certain types of Tylenol, Benadryl, and even the most easily obtainable form of Sudafed -- not to mention these medications’ generic equivalents.

But patients and doctors quickly began to notice that it wasn’t an effective substitute at all; phenylephrine doesn’t work as a decongestant.

What proof is there that phenylephrine doesn’t work as an oral decongestant?

It’s important to note that phenylephrine is effective in the other ways it’s used. It just doesn’t seem to work as a decongestant when taken orally (in nose spray form, on the other hand, it may be effective).

This is because it’s broken down by the metabolism before it can have an effect. The science has been put to the test in a number of studies that were conducted over the past decade-and-a-half.

Additionally, many patients avoid this drug, whether because their doctor advised them of it or simply from experience.

Why is phenylephrine still being marketed and sold as a decongestant?

In 2015, a citizens’ petition was filed by pharmacy researchers from the University of Florida, requesting the FDA to withdraw approval of phenylephrine as an oral decongestant. Over the years, numerous doctors and other healthcare professionals and organizations, including the American Academy of Allergy, Asthma and Immunology and the American College of Clinical Pharmacy have called for this withdrawal as well.

These pleas haven’t necessarily been ignored; in 2016 the FDA responded to the citizens’ petition by saying it was under review but that they can’t come to a decision, since more analysis is required. Nearly seven years later, phenylephrine is still an FDA-approved nasal decongestant.

A number of journalists have tried to understand the FDA’ s hesitancy to withdraw approval in the face of so much evidence. There seem to be two significant reasons:

First, there seems to be no other alternative to phenylephrine - no other over-the-counter medication that is relatively safe, and, possibly most importantly, can’t be used to make meth.

That said, science journalist Simon Oxenham reports that after the new legislation was put in place, the DEA reported a drop in meth lab activity, but it was short-lived. Oxenham wonders if the drop may may have also had to do with things like improved training.

The second reason for the FDA’s continued approval of phenylephrine may stem from the fact that since the drug isn’t treating a serious condition and doesn’t seem to be harming patients, it’s lower on the FDA’s priorities list.

This doesn’t take into account the horrendous pain of sinus congestion, which can be similar to a migraine if not treated with effective decongestants.

There’s also another issue to consider when it comes to patient well-being: money. Recent statistics show a staggering $10.82 billion was spent on cold and flu remedies this past year in the US alone.

The fact that so many of these medications are not actually helping people is deplorable, especially during an economic crisis. As Sage Therapeutics’ Adam Friedman puts it, “Healthcare is already expensive enough, let's use our money wisely and purchase/recommend things that actually treat our symptoms.”

Is there an effective oral decongestant patients can use?

Fortunately, there are alternatives to phenylephrine. Prescription medications may be an option, as well as over-the-counter nasal sprays (although these should only be used for up to three consecutive days).

But the most effective over-the-counter decongestant remains good old pseudoephedrine.

Those in the know are aware that it’s still available in US pharmacies - just not on the shelves. Instead, it has be be requested from the pharmacist, and is only given out in limited quantities. Purchasing it also involves showing identification and signing a registry. Still, as anyone who’s suffered from congestion - especially congestion tied to painful conditions like a sinus infection - will likely agree that the extra trouble is worth it if that’s what it takes to obtain medication that’s actually effective.

What can patients and healthcare providers do?

Friedman writes, “If the FDA plans to leave phenylephrine on the market, it is important for healthcare providers and patients alike to be educated on the most appropriate options for nasal congestion.”

Doctors, hospitals, and clinics should consider regularly informing patients about this issue, especially during cold season. Patient organizations and advocates should consider using social media to spread the word, as well. And if you’re reading this and feeling concerned and outraged, feel free to spread the word about phenylephrine, too.

Hopefully, continued criticism, studies, and scrutiny of phenylephrine will push the FDA to re-examine its approval . In the meantime, hopefully patient education around this issue will improve, as well.

Phenylephrine is considered a “safe” drug. But while it may have few side effects and be impossible to make methamphetamine with, it seriously harms patients’ level of well-being, and causes useless spending during an economic crisis - two severe side effects, indeed.

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